Manufacturer for Rapid Test For Covid-19 - SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold)-Home test – Macro & Micro-Test

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Manufacturer for Rapid Test For Covid-19 - SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold)-Home test – Macro & Micro-Test Detail:

Product name

SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Nasal

Certificate

CE1434

Epidemiology

Coronavirus Disease 2019(COVID-19), is a pneumonia caused by infection with a novel coronavirus named as Severe Acute Respiratory Syndrome Corona-Virus 2 (SARS-CoV-2). SARS-CoV-2 is a novel coronavirus in β genus, enveloped particles in round or oval, with a diameter from 60 nm to 140 nm. Human is generally susceptible to SARS-CoV-2. The main sources of infection are the confirmed COVID-19 patients and asymptomatic carrier of SARSCoV-2^[1].

Features

● Rapid: Read results in 15 minutes.
● Easy to use: Only 3 steps.
● Convenient: For self-test, home test.
● Room temperature: Transportation & storage at 4-30℃ for 24 months.
● Accuracy: High sensitivity & specificity.

Clinical study

The performance of Antigen Detection Kit was evaluated in 554 patients of nasal swabs collected from symptomatic suspects of COVID-19 within 7 days post symptom onset compared to RT-PCR assay. The performance of the SARS-CoV-2 Ag Test Kit is as follows:

SARS-CoV-2 Virus Antigen (investigational reagent)	RT-PCR reagent		Total
SARS-CoV-2 Virus Antigen (investigational reagent)	Positive	Negative	Total
Positive	97	0	97
Negative	7	450	457
Total	104	450	554

Sensitivity	93.27%	95.0% CI	86.62% – 97.25%
Specificity	100.00%	95.0% CI	99.18% – 100.00%
Total	98.74%	95.0% CI	97.41% – 99.49%

Technical Parameters

Storage temperature	4℃-30℃
Sample type	Nasal swab samples
Shelf life	24 months
Auxiliary instruments	Not required
Extra Consumables	Not required
Detection time	15-20 mins
Specificity	There is no cross-reactivity with pathogens such as human Coronavirus ( HCoV-OC43, HCoV-229E, HCoV-HKU1, HCoV-NL63), Novel influenza A H1N1 (2009), seasonal influenza A (H1N1, H3N2, H5N1, H7N9), Influenza B (Yamagata, Victoria), Respiratory syncytial virus A/B, Parainfluenza virus(1, 2 and 3), Rhinovirus (A, B, C), Adenovirus (1, 2, 3, 4,5, 7, 55).

Work Flow

1. Sampling
● Gently insert the entire soft tip of the swab (usually 1/2 to 3/4 of an inch) into one nostril, Using medium pressure, rub the swab against all the inside walls of your nostril. Make at least 5 big circles. And each nostril must be swabbed for about 15 seconds.Using the same swab, repeat the same in your other nostril.

Sampling

● Sample dissolving. Dip the swab completely into the sample extraction solution; Break the swab stick at the breaking point, leaving the soft end in the tube. Screw on the cap, invert 10 times and put the tube at a stable place.

2.Sample dissolving
2.Sample dissolving1

2. Perform the test
Put 3 drops of the processed extracted sample into the sample hole of the detection card, screw the cap.

Perform the test

3. Read the result (15-20mins)

Read the result

Precautions:
1. Do not read the result after 20 mins.
2. After opening, please use the product within 1 hour.
3. Please add samples in strict accordance with the instructions.

Key Components

Catalogue Number	Specification	Components	Quantity
HWTS-RT062I	1 test/kit	Test Card	1
		Sample Extraction Solution	1
		Disposable Swab	1
		Package Insert	1
HWTS-RT062IA	5 tests/kit	Test Card	5
		Sample Extraction Solution	5
		Disposable Swab	5
		Package Insert	1
HWTS-RT062IB	10 tests/kit	Test Card	10
		Sample Extraction Solution	10
		Disposable Swab	10
		Package Insert	1
HWTS-RT062IC	20 tests/kit	Test Card	20
		Sample Extraction Solution	20
		Disposable Swab	20
		Package Insert	1

Reference

[1] New Coronavirus Pneumonia Diagnosis and Treatment Plan. (Eighth Edition), National Health Office Medical Letter [2020] No. 680

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We stay with our company spirit of Quality, Performance, Innovation and Integrity. We goal to create more value for our clients with our abundant resources, advanced machinery, experienced workers and superb solutions for Manufacturer for Rapid Test For Covid-19 - SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold)-Home test – Macro & Micro-Test , The product will supply to all over the world, such as: Monaco, America, Karachi, We will continue to devote ourselves to market & product development and build a well-knit service to our customer to create a more prosperous future. Please contact us today to find out how we can work together.

Covid-19